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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 15, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 21, 2003
Recall NumberZ-0049-04
Recall Event ID 27299
510(K)NumberK945633 
Product Classification Endoscope, Neurological - Product Code GWG
ProductChannel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001
Code Information A20284
Recalling Firm/
Manufacturer		 Medtronic Neurosurgery
125 Cremona Drive
Goleta CA 93117
For Additional Information ContactJeffrey Henderson
805-826-5603 Ext. 1770
Manufacturer Reason
for Recall		Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
FDA Determined
Cause 2		Labeling mix-ups
ActionFirm sales representatives will contact customers and hand deliver the recall notice.
Quantity in Commerce10
DistributionTN, CO, GA and Japan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GWG
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